Enhanced standard care for treating mechanical neck pain

A Single-Center, Investigator-Blinded, Randomized, 4-Week, Parallel-Group, Superiority Study Comparing Contextual Factors-Enriched Standard Care Versus Standard Care Only for Patients with Mechanical Neck Pain (ContextualizAR Trial)

This study is testing if adding extra support for physical, mental, and social factors to standard care can help people with neck pain feel better and improve their daily activities.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidad Nacional de la Matanza (other)
• Locations: 1 site (Ciudad Autónoma de Buenos Aires, Buenos Aires)
• Trial ID: NCT06361472 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a Contextual Factors-Enriched Standard Care (CFs+SC) approach compared to standard care alone for patients suffering from mechanical neck pain. Over a 4-week period, participants will receive treatment twice weekly, with the intervention group benefiting from additional contextual factors that address physical, psychological, and social elements of care. The study will measure outcomes such as pain reduction and functional improvement using validated questionnaires and scales. The trial will also explore the impact of psychosocial conditions on treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with neck pain persisting for more than 4 weeks and no major structural pathology.

Not a fit: Patients with minor neck pain, recent cervical spine trauma, or serious underlying conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce pain and improve functional status for patients with mechanical neck pain.

How similar studies have performed: While the specific CFs+SC approach may be novel, similar studies have shown promise in enhancing treatment outcomes through contextual factors.

Eligibility criteria

Inclusion Criteria:

* Aged \>18.
* Neck pain for more than 4 weeks without signs or symptoms suggestive of major structural pathology.
* Read, write, and understand the Spanish language.
* Signed consent form.

Exclusion Criteria:

* Numeric Pain Reporting Scale (NPRS) \< 3 points (to ensure the exclusion of patients with minor disorders).
* Northwick Park Neck Pain Questionnaire (NPQ) \< 10 points (to ensure the exclusion of patients with minor disorders).
* History of cervical spine trauma, fracture, or surgical procedures.
* Signs and symptoms of cervical myelopathy and/or cervical radiculopathy (to rule out cervical radicular pain, the Spurling Test, the Upper Limb Tension Test for the median nerve, and the Traction/Distraction test will be used).
* Red flags or serious pathologies, such as malignancy, inflammatory or rheumatic diseases, infections, and vascular conditions like cervical artery insufficiency.

Where this trial is running

Ciudad Autónoma de Buenos Aires, Buenos Aires

• Hospital Donación Francisco Santojanni — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (RECRUITING)

Study contacts

• Principal investigator: Mauro F Andreu, PhD — Universidad Nacional de la Matanza
• Study coordinator: Mauro F Andreu, PhD

Conditions: Neck Pain, neck pain, functional status, contextual factors, placebo, randomized controlled trial